Pilot Testing the Check Up

Cannabis Use Disorder Clinical Trial

Official title:

Pilot Testing a TMCU Adapted for Young Adults With First Episode Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624074
• Other study ID #: 1R01MH120550-01A1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: University of Maryland, Baltimore
• Contact: Melanie Bennett, PhD
• Phone: 410-706-0892
• Email: mbennett[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We propose to pilot test an adapted version of the Teen Marijuana Check Up (TMCU) for persistent cannabis users with first episode psychosis (FEP) in Coordinated Specialty Care (CSC). The adapted version of the TMCU will include tailoring to risks of persistent cannabis use in FEP, providing education on lower risk cannabis use, and adding a session to address collaborative planning to maintain CSC engagement and antipsychotic adherence and to reduce harm associated with cannabis use.

Description:

We propose to adapt the Teen Marijuana Check Up for persistent cannabis users with FEP in CSC. Dr. Walker, the developer of the TMCU, will be a consultant. Adaptations will include tailoring content of assessment and feedback to risks of persistent cannabis use in FEP, providing education on lower risk cannabis use, and adding a session to address collaborative planning to maintain CSC engagement and antipsychotic adherence and to reduce harm associated with cannabis use. We will also develop guidelines for integrating continued collaborative, harm-reduction focused discussion of cannabis use into CSC, consider adding booster or check-in sessions, and specify how family members can be brought into the check-up process. To inform these adaptations, we will collect quantitative data from cannabis-using FEP patients (n of 40) and conduct qualitative interviews with cannabis-using patients, family members, and CSC clinicians (15 of each) about their perspectives on cannabis use and CSC participation (Aim 1). We will use these data as part of an iterative process to specify the adapted intervention that will integrate information gathered from team discussion and focus groups with FEP patients and family members and vetting of intervention components by key stakeholders (Aim 2). Finally, we will conduct a pilot of the adapted intervention (n of 40 cannabis-using FEP patients compared to matched controls) to examine feasibility, acceptability, fidelity, and preliminary impact on intervention targets and outcomes (Aim 3). If results are promising, the intervention can be tested in a large RCT across the EPINET.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Age 13-35

2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorder, and unspecified schizophrenia spectrum and other psychotic disorder

3. Duration of illness: = 2 years

4. Enrolled at a Coordinated Specialty Care program

5. Report current use of cannabis

6. Ability and willingness to provide informed consent to participate

Exclusion Criteria:

1. Individuals who do not meet all inclusion criteria are excluded.

Related Conditions & MeSH terms

• Cannabis Use Disorder

Intervention

Behavioral:
• Teen Marijuana Check Up
Teen Marijuana Checkup will be adapted for youth and young adults with first episode psychosis. The Teen Marijuana Checkup includes two intervention sessions. In Session 1, the interventionist uses motivational interviewing skills to hear the adolescent's history and current concerns with marijuana. The personalized feedback report generated from the baseline assessment is reviewed. In Session 2, the interventionist elicits change talk and guides discussion on making changes to reduce or stop marijuana use.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeline Followback	Change in cannabis use	baseline, immediately after the intervention
Primary	Modified Colorado Symptom Index	Change in psychosis symptoms	baseline, immediately after the intervention